Global Molecular Diagnostics Market Size By Product (Instruments, Reagents And Kits), By Technology (Polymerase Chain Reaction (PCR), Hybridization, Sequencing, Isothermal Nucleic Acid Amplification Technology (INAAT), Microarrays), By Application (Infectious Disease Diagnostics, Oncology Testing, Genetic Disease Testing), By End-User (Diagnostics Laboratories, Hospitals And Clinics), By Geographic Scope And Forecast

Molecular Diagnostics Market Size And Forecast

Molecular Diagnostics Market size was valued at USD 19.08 Billion in 2023 and is projected to reach USD 33.28 Billion by 2031, growing at a CAGR of 7.2% from 2024 to 2031.

• Molecular diagnostics is a set of tools for analyzing biological markers in the genome and proteome, with an emphasis on how genes are expressed in proteins. This approach brings molecular biology to medical testing, allowing for disease diagnosis and monitoring, genetic risk assessment, and personalized treatment strategies.
• Furthermore, applications include detecting infectious diseases (such as COVID-19 and tuberculosis), determining cancer risk through genetic testing (such as BRCA1/2 for breast cancer), and making therapeutic recommendations based on individual genetic profiles. Polymerase chain reaction (PCR) for amplifying DNA, next-generation sequencing for complete genomic analysis, and other assays to detect specific biomarkers in blood or tissue samples are all typical techniques used in molecular diagnostics.

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Global Molecular Diagnostics Market Dynamics

The key market dynamics that are shaping the molecular diagnostics market include:

Key Market Drivers:

• Increasing Incidence of Infectious Diseases: The rising prevalence of infectious diseases is a major driver in the molecular diagnostics market. According to the World Health Organization (WHO), approximately 10 million new cases of tuberculosis were reported worldwide in 2019. The COVID-19 pandemic has underlined the need for speedy and accurate molecular diagnostic techniques. According to the WHO, as of October 2023, there have been over 770 million confirmed cases of COVID-19 worldwide, showing the huge amount of testing necessary and spurring innovation in molecular diagnosis.
• Rising Cancer Prevalence and Demand for Personalized Medicine: The rising cancer incidence and the drive to individualized care are increasing the use of molecular diagnostics. According to the International Agency for Research on Cancer (IARC), there were 19.3 million new cancer cases worldwide in 2020, with a projected increase to 30.2 million by 2040. Molecular diagnostics are critical for cancer detection and treatment selection. According to the National Cancer Institute, the usage of next-generation sequencing for cancer diagnosis increased from 18% in 2014 to 40% in 2018, among oncologists surveyed in the United States.
• Advancements in Genomic Technologies and Decreasing Costs: Rapid developments in genomic technologies and lower costs are making molecular diagnostics more affordable. According to the National Human Genome Research Institute, the cost of sequencing a human genome dropped less than $1,000 in 2021, down from over $100 million in 2001. This considerable cost reduction has resulted in greater use of genetic testing in clinical settings. For example, the UK’s 100,000 Genomes Project, which finished in 2018, sequenced 100,000 genomes from NHS patients with uncommon disorders and their families, as well as cancer patients, proving the widespread use of molecular diagnostics in healthcare systems.

Key Challenges:

• High Cost of Diagnostic Products: The high cost of diagnostic products is a significant challenge for the molecular diagnostics market. Molecular diagnostic devices and tests necessitate significant investment in specialized equipment and reagents, making them available largely to major hospitals and reference laboratories. Smaller clinics and healthcare facilities struggle to finance this technology, restricting the widespread adoption of molecular diagnostics and perhaps impeding advances in patient care and early illness identification.
• Presence of Alternative Diagnostic Technologies: The presence of alternative diagnostic technologies presents a challenge to the molecular diagnostics market. Traditional laboratory testing and quick antigen tests are considered less expensive and easier to implement than molecular approaches. These alternatives reduce market share for molecular diagnostics, particularly in resource-constrained environments where healthcare providers prefer simpler, faster, and less expensive testing choices. This competition slows the growth of molecular diagnostics, despite its benefits in accuracy and specificity.

Key Trends:

• Rise of Next-Generation Sequencing (NGS): NGS technologies have transformed this field by enabling full genomic profiling, which enables the detection of genetic alterations linked to a variety of disorders, including cancer. This innovation enables personalized medicine, in which treatment strategies can be modified based on individual genetic profiles, thereby improving patient outcomes and increasing the efficacy of targeted medicines in oncology and beyond.
• Growth of Point-of-Care Testing (POCT): POCT devices provide quick, on-site diagnoses without the need for specialist laboratory facilities, making them especially useful in resource-constrained environments and during outbreaks. This shift toward instant testing improves patient management by allowing medical professionals to make faster treatment decisions, increasing access to care, and shortening the period between diagnosis and intervention, particularly for infectious disorders.

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Global Molecular Diagnostics Market Regional Analysis

Here is a more detailed regional analysis of the molecular diagnostics market:

North America:

• According to Verified Market Research, North America is estimated to dominate the molecular diagnostics market during the forecast period. North America, particularly the United States, has a high burden of chronic diseases and cancer, which drives the need for molecular diagnostics. According to the Centers for Disease Control and Prevention (CDC), six out of every ten persons in the United States have a chronic disease, with four out of ten having two or more. The American Cancer Society predicts that 1.9 million new cancer cases will be detected in the United States by 2023. The increased illness load necessitates the use of modern diagnostic technologies. According to the National Cancer Institute, the usage of next-generation sequencing in cancer detection increased from 18% in 2014 to 40% in 2018, demonstrating that molecular diagnostic approaches are becoming more widely adopted.
• Furthermore, North America’s strong healthcare infrastructure and attractive reimbursement policies help to drive the molecular diagnostics market forward. The Centers for Medicare & Medicaid Services (CMS) reports that national health spending in the United States reached USD 4.3 Trillion in 2021, accounting for 18.3% of GDP. In 2018, the CMS announced coverage for Next Generation Sequencing (NGS) testing for patients with advanced cancer, significantly improving access to molecular diagnosis. This judgment applies to FDA-approved companion diagnostic tests for patients with recurrent, metastatic, relapsed, refractory, or advanced stage III or IV cancer.

Asia Pacific:

• The Asia Pacific region is estimated to exhibit the highest growth within the market during the forecast period. The Asia Pacific region is facing a huge challenge from infectious diseases, which is boosting demand for molecular diagnostics. According to the WHO, roughly 3.1 million new tuberculosis cases were reported in Southeast Asia in 2019. This high infectious illness load demands quick and precise diagnostic tools. For example, India’s Revised National TB Control Programme (RNTCP) has significantly increased the use of molecular diagnostic tests, with over 1,180 CBNAAT (Cartridge Based Nucleic Acid Amplification Test) machines installed across the country by 2020, capable of performing more than 15 million tests per year.
• Furthermore, cancer rates are quickly increasing in the Asia Pacific region, accelerating the adoption of molecular diagnostic technology for early detection and individualized therapy. According to the International Agency for Research on Cancer (IARC), Asia will account for over half of the global cancer burden by 2020, with 9.5 million new cancer cases. In China, the National Cancer Center recorded 4.57 million new cancer cases in 2020. To address this growing worry, governments are investing in molecular diagnostics. For example, from 2018 to 2021, Japan’s Ministry of Health, Labour, and Welfare approved 13 cancer genomic profiling tests, reflecting the region’s dedication to improved cancer diagnostics.

Global Molecular Diagnostics Market: Segmentation Analysis

The Global Molecular Diagnostics Market is segmented based on Product, Technology, Application, End-User, and Geography.

Molecular Diagnostics Market, By Product

• Instruments
• Reagents and Kits

Based on Product, the market is segmented into Instruments and Reagents & Kits. The reagents & kits segment is estimated to dominate the molecular diagnostics market due to their widespread use in diagnostic applications such as infectious disease testing and cancer screening. Reagents and kits are vital for molecular testing because they provide flexibility and adaptability to satisfy a wide range of clinical needs. Furthermore, continued technological developments and growing awareness of early disease diagnosis fuel demand for these goods, reinforcing their market leadership.

Molecular Diagnostics Market, By Technology

• Polymerase Chain Reaction (PCR)
• Hybridization
• Sequencing
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Microarrays
• Others

Based on Technology, the market is divided into Polymerase Chain Reaction (PCR), Hybridization, Sequencing, Isothermal Nucleic Acid Amplification Technology (INAAT), Microarrays, and Others. The polymerase chain reaction (PCR) segment is estimated to dominate the market during the forecast period due to PCR’s vital role in amplifying specific DNA sequences, which is required for a variety of applications such as infectious disease detection and genetic testing. Its versatility and dependability have resulted in widespread usage in clinical and research settings, making it a key technology in molecular diagnostics and generating significant growth in this field.

Molecular Diagnostics Market, By Application

• Infectious Disease Diagnostics
• Oncology Testing
• Genetic Disease Testing
• Others

Based on Application, the market is segmented into Infectious Disease Diagnostics, Oncology Testing, Genetic Disease Testing, and Others. The infectious disease diagnostics segment is estimated to lead this segment in the forecast period. This dominance is primarily driven by the rising occurrence of infectious diseases and the increased demand for rapid, precise diagnostic procedures, as demonstrated during the COVID-19 pandemic. The widespread adoption of technologies such as polymerase chain reaction (PCR) has strengthened this segment’s position, as they are critical for the rapid detection and management of many infectious diseases, hence improving patient outcomes and public health responses.

Molecular Diagnostics Market, By End-User

• Diagnostics Laboratories
• Hospitals and Clinics
• Others

Based on End-User, the market is segmented into Diagnostics Laboratories, Hospitals & Clinics, and Others. The hospitals & clinics segment is estimated to dominate the market during the forecasted period due to an increase in the number of patients who require molecular analysis for a variety of disorders, including infectious diseases and cancer. Hospitals are outfitted with advanced treatment facilities and specialized skills, allowing them to efficiently use molecular diagnostics for timely diagnosis and tailored treatment regimens. This trend is projected to continue as more healthcare systems use these technologies to improve patient care.

Key Players

The “Molecular Diagnostics Market” study report will provide valuable insight with an emphasis on the global market. The major players in the market are Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Bio-Rad Laboratories, QIAGEN, Siemens Healthineers, Becton, Dickinson and Company (BD), Hologic, Inc., Danaher Corporation, and Agilent Technologies.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Molecular Diagnostics Market Recent Developments

• In February 2023, Thermo Fisher Scientific, Inc. acquired Binding Site Group (UK), an international leader in specialized diagnostics, expanding Thermo Fisher’s current specialty diagnostics portfolio with pioneering innovation in multiple myeloma diagnosis and monitoring.
• In October 2022, F. Hoffmann-La Roche Ltd. gained 510(k) approval from the US FDA for the cobas SARS-CoV-2 Qualitative PCR test for use with the entirely computerized cobas 6800 and cobas 8800 systems.
• In May 2022, F. Hoffmann-La Roche Ltd. collaborated with the Global Fund to help countries with low or middle incomes develop vital diagnostics infrastructure.
• In December 2021, Hologic Inc. introduced Panther Trax for large quantities of molecular testing.
• In March 2021, Abbott Laboratories received Emergency Use Authorization (EUA) from the FDA for Alinity m Resp-4-Plex molecular assay, a laboratory PCR assay that detects and distinguishes between SARS-COV-2, flu A, flu B, and RSV in a single test.

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